What did the company know and when did it know it; what communications ensued about the cost and scope of a possible recall; what lots would be recalled; what science exists to assure the safety of mesh that appears to be disintegrating, even before it's removed from its packaging.
The 15 page motion, filed by Christy Jones, of Butler Snow LLP, Ethicon's lead attorney, says the documents requested contain personal and private information. To release them might violate HIPPA the Health Insurance Portability & Accountability Act of 1996. Additionally, many of the documents are attorney work product therefore privileged.
Sources suggest that if a CC to a lawyer is added to any email it could be put into the attorney work product category, therefore it could be argued it's out of reach.
Jones argues to the court that the document production is overly broad and ambiguous, not relevant, unduly burdensome and oppressive. It was filed in U.S. District Court in the Southern District of WV where 75,000 pelvic mesh cases have been consolidated in multidistrict litigation before Judge Joseph Goodwin.
Here is Ethicon Doc #1627 filed July 6, 2015.
The company executives will be asked why Ethicon's TVT (transvaginal tape), including the TVT-O mesh (transobturator tape) has had a problem with mesh particles and possible foreign matter found in the packaging material and why the company issued assurances of safety to doctors if the degrading products are used in patients.
The complaints began to come in from a hospital in Taiwan in July 2010. Doctors found boxes with tiny blue particles in the mesh product packaging and sent it back to the company's New Jersey headquarters. In all, ten boxes of TVT-O were returned to the company.
Darlene Kyle from Ethicon told the J&J rep from Medical Taiwan, the corporate communications department of J&J in Taiwan. “No this is not normal nor do we recommend using the product.”
But later she asked Ethicon’s headquarters for a "formal letter saying it’s safe” that would be shown to implanting physicians.
Meng Chen of Ethicon, who was in charge of customer complaints, writes in an October 5, 2010 email, “After careful review of the available information in the files and the information provided from the manufacturing site, the Business Unit Medical Director and I feel that the possibility for the tiny tape fragments observed in these five cases to cause adverse consequence in a patient, a device administrator or others should be considered remote. The presence of tiny tape fragments in the product package is not expected to change the product safety profile.”
What was the scientific basis for that conclusion plaintiffs’ attorneys will want to know.
The deposition request was filed by Tom Cartmell of Wagstaff and Cartmell of Kansas City, Missouri. The Notice to Take Oral Depositions was filed June 25 in the multidistrict litigation before Judge Joseph Goodwin in Charleston, West Virginia. The Ethicon MDL is 2:12-md-02327. This was Document #1609, #1609-1, #1609-2.
Attorneys will ask the corporate representatives how many complaints they received of particles or foreign material in TVT packaging or products; for any correspondence regarding whether the meshes were safe to use; communications regarding the cost of any potential recall of any TVT lot; the actual letter supplied to doctors that the product is safe to use; the scientific analysis of patient consequences of particles or foreign matter that might inadvertently be implanted or break off in the human body; communications regarding the returned products and any testing or analysis conducted on the products; documents concerning the cleaning of equipment used for cutting, packaging or sterilizing said mesh products and any inspections that should have occurred, among other questions.
There is no word yet on who Ethicon will send though Meng Chen has appeared on behalf of Ethicon at trial.
Ethicon makes pelvic meshes as a division of Johnson & Johnson. At this writing the company is facing 26,851 product liability lawsuits (here) consolidated in this one federal court as well as cases filed in state courts around the country. Women complain the permanent implants have left them in pain, with chronic infection and many are unable to walk or to work. The mesh was originally used to address incontinence and many complain it was ineffective in that regard.
J&J has more defective product cases than another of the seven manufacturers, yet it has offered no mass settlements to date, just individual settlements during or before trial.
Attached to this filing is an Ethicon publication “Particles in TVTO Blisters” which refers to packaging, issued by the company office in Switzerland. It says “Since July 2010, 6 complaints have been recorded for the following issue: Foreign Matter in TVTO blisters.” It lists the foreign matter found in J&J (Ethicon) packing of TVT products sold to Taiwan and South Africa.
Women affected by pelvic mesh have also noted the breakdown of particles in packaging of products purchased online, even among meshes that are within their shelf life.
Mesh particles are thought to incite foreign body response to the polypropylene and may create biofilms that protect colonies of bacteria that continue to thrive even after mesh implant is removed.
Mesh is cut both by machine and by laser. The Swiss publications says “Particles belonging to the product in the blister (blue or white based on mesh being process) inferior to 0.4mm2 or 3mm is acceptable” while particles not belonging to the product are not acceptable. #